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Abstract Background The integration of telehealth interventions into clinical practice is frequently delayed, hindering the full adoption. Previously, we developed a digital patient education (PE) programme for self-management in rheumatoid arthritis (RA). While the programme design considered crucial factors to ensure the likelihood of success in clinical practice, there is a need for a systematic evaluation of implementation perspectives. The purpose of this study was to explore perspectives crucial to implementation of a digital PE programme in clinical practice. Methods The non-adoption, abandonment, scale-up, spread and sustainability (NASSS) framework was used to evaluate the successes and challenges of implementing the digital PE programme. We included a data set consisting of qualitative focus group discussions involving study nurses, rheumatologists, and leaders from rheumatology departments. Data analysis was guided by a deductive content analysis approach. Further we included data from earlier studies pertaining to the programme’s implementation, comprising the programme development process, a randomized controlled trial evaluating the programme’s effectiveness, and a qualitative study exploring patients’ perspectives of the programme. Results Facilitators and challenges of importance to implementation of digital PE were identified. While a wide range of patients could benefit from using digital PE, future implementation should aim for an even broader group than those studied. Both patients and healthcare providers embraced the technology, and the fact that it did not require specific technical skills enhances its potential for success. However, offering digital PE should be based on individual assessments, and expanding its use will require organizational adjustments. An adaptable structure is needed to accommodate unforeseen care needs that may arise following the use of digital PE at home. There was indication of some reluctance among healthcare providers toward the programme shown by concerns about changing roles, which could impact the adoption of the program. Conclusions The design and ease of use of the technology, the program’s effectiveness, its availability, and the potential to release healthcare resources may encourage the implementation of digital patient education. Challenges associated with implementing this mode of care pertains to the condition and the patient population, user adoption of the technology, and the organization of patient education. Trial registration The study is registered by the Central Denmark Region Scientific Committee (no. 1-16-02-52-19).

Purpose It is well-documented that people with inflammatory arthritis (IA) exhibit a high prevalence of symptoms related to anxiety and depression. Less is known about what contributes to good mental health in people with IA. Therefore, this study aims to explore how some patients maintain good mental health despite living with IA. Methods Explorative qualitative interview study (one focus group, 12 individual interviews, n = 18) utilizing purposeful sampling. All interviews were audiotaped, transcribed, and managed using NVivo14 and employed a reflexive thematical analysis approach. Results We identified four main themes: 1) Assisted by a positive outlook on life—how participants’ inherent positivity helped them cope with arthritis; 2) Moving towards acceptance of life with arthritis—how participants embraced the reality of living with IA; 3) Counteracting letting arthritis dictate one’s life how the participants structured their lives in terms of physical activity and social connections; and 4) Taking responsibility for the trajectory—how the participants were mindful of their bodies and took the initiative to explore new treatments. Conclusion People living with IA maintain good mental health by engaging in structured physical activity, fostering social connections, and cultivating a positive outlook on life. These insights can inform the development of future treatment and support strategies.

Objective To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR).Methods A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies.Results Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid.Conclusion There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.

BackgroundIn Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice. ObjectiveThis study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement. MethodsA process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians. ResultsOf the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient’s health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment. ConclusionsThis study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their “clinical glance,” posing a potential risk of overlooking crucial patients‘ symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns. Trial RegistrationClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766

Abstract Background Supporting adherence to medication is an essential part of the treatment and care of patients with rheumatic and musculoskeletal diseases. The Compliance Questionnaire Rheumatology (CQR) measures adherence in rheumatic diseases through 19 items covering drug-taking behaviour to identify the reasons for adhering to treatment and the factors that contribute to suboptimal adherence. The objective of this study was to present the translation of the CQR into Danish and the face validity and reliability test. Methods The CQR was translated into Danish according to international guidelines, followed by a face validity test among 10 patients with rheumatoid arthritis in 2009. The test–retest reliability of the Danish CQR was evaluated in 49 patients with rheumatoid arthritis in 2020 - 2021 using the standard error of the measurement (SEM) converted into the minimally detectable change (MDC) and the intraclass correlation coefficient (ICC). Questionnaires were administered with a minimum of 10 days between assessments. Results The participants in the reliability test had a mean age of 57.4 years (SD 16.1) and a mean disease duration of 1.13 years (range 2 months–2 years). The mean CQR score in the test and retest was 62.7 (confidence interval (CI) 58.8; 66.6) and 62.5 (CI 58.9; 66.1), respectively, with a SEM of 8.59 (7.16; 10.73) and an MDC of 16.83. A satisfactory test–retest reliability was confirmed by an ICC value of 0.79 (CI 0.68; 0.89). Conclusion The Danish CQR has satisfactory test–retest reliability in patients newly diagnosed with rheumatoid arthritis and is considered a reliable tool to measure adherence in this group.

Objective To investigate the prevalence of anxiety and depression among patients with inflammatory arthritis (IA) and evaluate the association of these mental health issues with self-management behaviour.Methods In this nationwide cross-sectional study, we analysed data from 12 713 adult Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SpA). Patients received an electronic questionnaire covering sociodemographics, self-management behaviour and mental health status. Questionnaire data were linked to clinical data from the Danish Rheumatology database (DANBIO) and the Danish National Patient Registry. The prevalence of anxiety and depression (by the Hospital Anxiety and Depression Scale for Anxiety (HADS-A) and Depression (HADS-D)) was estimated separately for RA/PsA/SpA. The association between mental health status and low self-management behaviour (adherence to treatment, health activation and physical activity) was estimated using multivariable logistic regression, adjusting for age, sex, educational level and comorbidity.Results The prevalence of anxiety (HADS-A≥8) was highest for patients with SpA (34.5% (95% CI 32.4% to 36.6%)) and lowest for patients with RA (22.1% (95% CI 21.2% to 23.0%)), it was higher for women, younger (

BackgroundPatients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist health care to maintain low disease activity. The follow-up has been organized as prescheduled face-to-face visits, which are time-consuming for both patients and health care professionals. Technology has enabled the remote monitoring of disease activity, allowing patients to self-monitor their disease and contact health care professionals when needed. Remote monitoring or self-monitoring may provide a more personalized follow-up, but there is limited research on how these follow-up strategies perform in maintaining low disease activity, patient satisfaction, safety, and cost-effectiveness. ObjectiveThe Remote Monitoring in Axial Spondyloarthritis (ReMonit) study aimed to assess the effectiveness of digital remote monitoring and self-monitoring in maintaining low disease activity in patients with axial spondyloarthritis. MethodsThe ReMonit study is a 3-armed, single-site, randomized, controlled, open-label noninferiority trial including patients with axial spondyloarthritis with low disease activity (Ankylosing Spondylitis Disease Activity Score

Background Ongoing education of health professionals in rheumatology (HPR) is critical for high-quality care. An essential factor is education readiness and a high quality of educational offerings. We explored which factors contributed to education readiness and investigated currently offered postgraduate education, including the European Alliance of Associations for Rheumatology (EULAR) offerings.Methods and participants We developed an online questionnaire, translated it into 24 languages and distributed it in 30 European countries. We used natural language processing and the Latent Dirichlet Allocation to analyse the qualitative experiences of the participants as well as descriptive statistics and multiple logistic regression to determine factors influencing postgraduate educational readiness. Reporting followed the Checklist for Reporting Results of Internet E-Surveys guideline.Results The questionnaire was accessed 3589 times, and 667 complete responses from 34 European countries were recorded. The highest educational needs were ‘professional development’, ‘prevention and lifestyle intervention’. Older age, more working experience in rheumatology and higher education levels were positively associated with higher postgraduate educational readiness. While more than half of the HPR were familiar with EULAR as an association and the respondents reported an increased interest in the content of the educational offerings, the courses and the annual congress were poorly attended due to a lack of awareness, comparatively high costs and language barriers.Conclusions To promote the uptake of EULAR educational offerings, attention is needed to increase awareness among national organisations, offer accessible participation costs, and address language barriers.

BackgroundPatient-reported outcomes (PROs) are increasingly used in outpatient follow-up. PRO-based remote follow-up offers a new healthcare delivery model, where PROs are used as the basis for outpatient follow-up in patients with chronic kidney disease. However, the patient's perspective of this novel remote care delivery remains unknown.ObjectivesThis study aimed to explore the patients' experiences using PROs in remote care and how this mode of follow-up may enhance patient engagement.DesignA qualitative approach was employed, guided by Focused Ethnography and Interpretive Description.ParticipantsPurposively, 15 patients with chronic kidney disease experienced with PRO-based remote follow-up in 3 renal outpatient clinics in the Central Denmark Region, were recruited.MeasuresField studies comprising participant observation in remote PRO consultations and individual, semi-structured interviews with the patients constituted the empirical data. Thematic analysis was performed according to Braun and Clarke's six-phase process.ResultsPRO-based remote follow-up may enhance patient engagement by a) improving communication, b) increasing disease knowledge, c) inducing flexibility, d) ensuring clinician feedback on PRO data, and e) prompting clinical action. Barriers to enhanced patient engagement were identified as a) lack of feedback on PRO data, b) lower disease knowledge, c) PRO in competition with biomedical data, and d) loss of personal relation.ConclusionPRO-based follow-up in remote care holds several advantages for the patients. However, some barriers need clinical awareness before PROs may enhance the patients' engagement in remote follow-up. Future studies should explore the impact of involving relatives in PRO-based follow-up.

Abstract Background Patient education is integral to the treatment and care of patients with rheumatoid arthritis. Change is taking place in the organisation of healthcare systems because of a demographic shift towards ageing populations, an increasing use of technology and advancements in digital technologies, allowing for new interventions. This study will aim to evaluate the effectiveness of a newly developed e-learning patient education programme based on self-management that targets patients with rheumatoid arthritis. Methods A pragmatic multi-centre randomised controlled trial is planned. We intend to recruit approximately 200 patients with a new diagnosis (

Abstract Background Patient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but not sufficiently evaluated through clinimetrics in clinical setting. Hence, we aimed to evaluate the content validity, construct validity and the test–retest reliability of a renal disease questionnaire to be used for clinical decision-making. Methods A content, construct validity and test–retest reliability study was conducted in 3 nephrology outpatient clinics in Central Denmark Region, Denmark. Content validity (face validity, comprehensibility and relevance) was assessed among 8 patients and 6 clinicians. Reliability was assessed by asking outpatients with chronic kidney disease to complete the questionnaire twice. Reliability was assessed by kappa statistics and agreement by percentage. Construct validity was determined using 4 a priori defined hypotheses and comparing 2 known groups. Results Five new domains emerged, 6 items were rephrased and 3 items were removed following the content validity test. A total of 160 patients completed the questionnaire with median 8 days (IQR 2 days) between assessments. The test–retest reliability parameters of the single items in the questionnaire were substantial to almost perfect as all the observed weighted kappa values ranged from 0.61 to 0.91, 95% CI (0.34 to 0.95). In total, 61% of the single items showed almost perfect agreement. In total, 3 of the 4 hypotheses were accepted and 44% of the items showed satisfying known-group discriminative validity. Conclusion A renal disease questionnaire used for clinical decision-making in outpatient follow-up showed acceptable content validity and substantial to almost perfect reliability. Sufficient construct validity was not established. Incorporating the questionnaire into routine clinical practice may improve the evaluation of disease burden in patients with chronic kidney disease. Plain English summary We ask patients with chronic kidney disease (CKD) in Central Region Denmark to complete a questionnaire before each outpatient visit. The answers they provide are used to support communication with their health care provider. A questionnaire requires testing to ensure it can accurately capture important information about patient’s symptoms and quality of life. When questionnaires are used to support communication between patients and health care professionals, they need to have good measurement properties. This means they need to be: (1) trustworthy, (2) relevant to a patient’s health condition, (3) consistent and produce stable results every time. We explored the measurement properties of a questionnaire designed to be used in the face-to face outpatient visits for patients with CKD. We found that the questionnaire captured consistent and stable results. Using this questionnaire may help health care professionals to assess the patients´ burden of symptoms with a more patient-centered approach. Potentially, the use of the questionnaire will increase the patients´ ability to cope with their symptoms and strengthen patients´ involvement in the clinical decisions concerning their treatment.

Objective To identify measures used within Denmark evaluating any type of intervention designed to facilitate patient involvement in healthcare.Design Environmental scan employing rapid review methods.Data sources MEDLINE, PsycInfo and CINAHL were searched from 6–9 April 2021 from database inception up to the date of the search.Eligibility criteria Quantitative, observational and mixed methods studies with empirical data on outcomes used to assess any type of intervention aiming to increase patient involvement with their healthcare. Language limitations were Danish and English.Data extraction and synthesis Two independent reviewers extracted data from 10% of the included studies and, due to their agreement, the data from the rest were extracted by first author. Data were analysed with reference to existing categories of measuring person-centred care; findings were synthesised using narrative summaries. Adapted Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines were used to guide reporting.Results Among 3767 records, 43 studies met the inclusion criteria, including 74 different measures used to evaluate interventions aimed at increasing patient involvement within healthcare in Danish hospital and community settings. Generic measures assessed: patient engagement (n=3); supporting self-management (n=8); supporting shared decision-making (n=9); patient satisfaction and experiences of care (n=11); health-related patient-reported outcome (n=20).Conclusions Across Denmark, complex interventions designed to improve patient involvement with healthcare vary in their goals and content. Some targeting healthcare professionals, some patient health literacy and some service infrastructure. A plethora of measures assess the impact of these interventions on patient, professional and service delivery outcomes. Few measures assessed patient involvement directly, and it is unclear which proxy measures capture indicators of perceived involvement. Lack of conceptual clarity between intervention goals, the components of change and measures makes it difficult to see what types of intervention can best support change in services to ensure patients are more effectively involved in their healthcare.

Objective: To develop an e-learning education program targeting patients with rheumatoid arthritis. Methods: The development process involved content specification and creative design. It was theoretically framed within theories of multimedia learning and entertainment-education and empirically based on evidence of patient education in rheumatoid arthritis and focus group discussions with stakeholders. We conducted a feasibility test among ten patients to assess the acceptability and usability of the program, and to identify areas to be adjusted. Results: The following themes for educational needs were found in focus group discussions: “Knowledge of rheumatoid arthritis,” he disease course and prognosis,” “Medical treatment,” “A new life situation” and “Daily life with rheumatoid arthritis.” Based on this, an e-learning program covering the disease course, examinations, treatment, and daily life, was created. It combines animations, videos, podcasts, text, speech, and tests. Test persons found the program feasible—that is, clear in content and easy to understand with a suitable pace and coherence between graphics, speech, and text. Conclusion: This e-learning program is based on solid theoretical knowledge that meets users' needs and is easy to use. Innovation: This study contributes to the innovation of health care by the development of a new digital tool for patient education.

Objective To explore the perspectives of general practitioners (GPs) on facilitators and barriers in diagnosing rheumatoid arthritis (RA). Design Qualitative study based on focus group interviews, and using latent thematic analysis. Setting General practices from Central Region Denmark. Subjects Eleven GPs participated in three different focus groups. Forty percent were female, the mean age was 53 years (range 37–64), and the mean since medical licensing was 16 years (range 5–23). Sixty percent of the GPs worked in an area served by a university hospital, and 40% were served by a regional hospital. Main outcome measure Themes describing experiences and reflections about facilitators and barriers in diagnosing Rheumatoid Arthritis. Results Four themes emerged: (A) If the patient is not a textbook example, (B) The importance of maintaining the gatekeeper function, (C) Difficulties in referral of patients to the rheumatologist, and (D) Laboratory tests—can they be trusted? Barriers were identified in all themes, but facilitators only in A, C, and D. The overarching theme was Like finding a needle in a haystack. Conclusion The GPs found several barriers for diagnosing RA (symptom awareness, GP’s gatekeeper function, suboptimal collaboration with rheumatologists and limitations in laboratory tests). They identified education, more specific tests and better access to rheumatologists as possible facilitators for diagnosing RA. To facilitate earlier referral of suspected RA in general practice and strengthen mutual information and collaboration, future research should focus on these facilitators and barriers.Keypoints Early diagnosis is essential for the prognosis of RA, and the diagnostic process begins in general practice. Suggested facilitators: training courses in interpretation of laboratory tests and the clinical manifestation of RA, and videos on joint examinations. Suggested barriers: compliance with the gatekeeper function, suboptimal collaboration with rheumatologists, limitations of laboratory tests, and diversity of clinical manifestations.

Abstract Background Self-administration of medication (SAM) during hospitalization is a complex intervention where patients are involved in their course of treatment. The study aim was to pilot test the SAM intervention. The objectives were to assess the feasibility of conducting a randomized controlled trial on the safety and cost-consequences of SAM during hospitalization. Methods The study was performed in a Danish cardiology unit. Patients ≥ 18 years capable of self-administering medication during hospitalization were eligible. Patients were excluded if they did not self-administer medication at home, were incapable of self-administering medication, were not prescribed medication suitable for self-administration, did not bring their medication, or were unable to speak Danish. Feasibility was assessed as part of the pilot study. A future randomized controlled trial was considered feasible if it was possible to recruit 60 patients within 3 months, if outcome measurement method was capable of detecting dispensing errors in both groups, and if patients in the intervention group were more satisfied with the medication management during hospitalization compared to the control group. Forty patients were recruited to gain experience about the intervention (self-administration). Additionally, 20 patients were randomized to the intervention or control group (nurse-led dispensing) to gain experience about the randomization procedure. Dispensing error proportions were based on data collected through disguised observation of patients and nurses during dispensing. The error proportion in the control group was used for the sample size calculation. Patient acceptability was assessed through telephone calls. Results Of the 60 patients recruited, one withdrew and 11 were discharged before observation resulting in analysis of 39 patients in the intervention group and nine in the control group. A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group. A total of 91.7% of patients in the intervention group and 66.7% in the control group were highly satisfied with the medication management during hospitalization. The overall protocol worked as planned. Minor changes in exclusion criteria, intervention, and outcome measures were considered. Conclusions It may be feasible to perform a pragmatic randomized controlled trial of the safety and cost-consequences of self-administration of medication during hospitalization. Trial registration ClinicalTrials.gov, NCT03541421 , retrospectively registered on 30 May 2018.

The COVID-19 pandemic has become an unprecedented facilitator of rapid telehealth expansion within rheumatology. Due to demographic shifts and workforce shortages in the future, new models of rheumatology care will be expected to emerge, with a growing footprint of telehealth interventions. Telehealth is already being used to monitor patients with rheumatic diseases and initial studies show good results in terms of safety and disease progression. It is being used as a tool for appointment prioritization and triage, and there is good evidence for using telehealth in rehabilitation, patient education and self-management interventions. Electronic patient-reported outcomes (ePROs) offer a number of long-term benefits and opportunities, and a routine collection of ePROs also facilitates epidemiological research that can inform future healthcare delivery. Telehealth solutions should be developed in close collaboration with all stakeholders, and the option of a telehealth visit must not deprive patients of the possibility to make use of a conventional ‘face-to-face’ visit. Future studies should especially focus on optimal models for rheumatology healthcare delivery to patients living in remote areas who are unable to use or access computer technology, and other patient groups at risk for disparity due to technical inequity and lack of knowledge.

Abstract Background The use of patient-reported outcome (PRO) could potentially contribute to the reorganization of the health care system. AmbuFlex is a PRO system used in remote patient monitoring, in which questionnaires are sent to patients at fixed intervals. The PRO data are used by clinicians to decide whether patients need clinical attention. Better self-management and cost-saving follow-up activities may be achieved by letting patients initiate need of contact. We evaluated the effects of patient-initiated PRO-based outpatient follow-up on health care resource utilization, quality of care, and the patient perspective. Methods We conducted a parallel two-arm pragmatic randomized controlled trial at the Department of Neurology, Aarhus University Hospital, Denmark. Outpatients with epilepsy (≥ 15 years old), attending fixed-interval PRO-based follow-up with web-based questionnaires, were randomly assigned in a ratio of 0.55:0.45 to either 1) patient-initiated PRO-based follow-up (open access telePRO) or 2) fixed-interval PRO-based follow-up (standard telePRO). The primary outcome was the number of outpatient hospital contacts related to epilepsy retrieved from a regional registry. Hospitals admissions and emergency room visits were also assessed. Secondary self-reported outcomes including general health, well-being, health literacy, self-efficacy, number of seizures, side effects, confidence, safety, and satisfaction were retrieved from questionnaires. Data were analyzed by the intention-to-treat and per-protocol approaches. Results Between January 2016 and July 2016, 593 patients were randomized to either open access telePRO (n = 346) or standard telePRO (n = 247). At 18 months, no statistically significant differences were found between the arms regarding number of telephone consultations or outpatient visits. Patients in the open access arm had a slightly lower, statistically significant number of emergency room visits than patients in the standard arm. Self-reported mental well-being in the open access arm was slightly, statistically significantly lower than in the standard arm. Other secondary outcomes did not differ statistically significantly between arms. Conclusion This study did not find, as hypothesized, less use of health care resources or improved patient self-management or satisfaction in the patient-initiated PRO-based initiative compared to fixed-interval PRO-based follow-up. Patient-initiated PRO-based follow-up may be used as an alternative to fixed-interval PRO-based follow-up in patients who prefer this approach, but there is insufficient evidence for recommending a system-wide shift to patient-initiated PRO-based follow-up. Trial registration Registered 4 February 2016 with ClinicalTrials.gov: NCT02673580.

Abstract Background Outpatient care is steadily changing from hospital consultations to other platforms, such as phone consultation and online virtual clinics. It is prudent to maintain quality of care with such initiatives. Currently, patients with chronic kidney disease (CKD) have frequent scheduled visits, but it may be possible to optimise the frequency of hospital consultations using information from patient-reported outcome (PRO) questionnaires filled in at home (PRO-based follow-up). This approach may provide a more individually tailored follow-up based on actual needs for clinical attention. We aimed to evaluate the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD. Methods This study is a pragmatic, non-inferiority, randomised controlled trial in outpatients with CKD (Grove BE et al., Qual Life Res 27: S143, 2018). Newly referred patients with an estimated glomerular filtration rate (eGFR) of ≤40 ml/min 1.73m2 will be randomised to either: 1.PRO-based remote follow-up2.PRO-based telephone consultation3.Usual outpatient follow-up (control group) In the two intervention groups, a diagnosis-specific PRO questionnaire completed by the patient at home will substitute for usual outpatient follow-up visits. The PRO questionnaire will in part be used as a screening tool to identify patients in need of outpatient contact and to identify focus areas. Responses from the questionnaire will be processed according to a disease-specific algorithm and assigned green, yellow or red status according to patients’ needs. The primary outcome will be loss of renal function evaluated by eGFR. Secondary outcomes are 1. Clinical outcomes, including initiation of acute dialyses, hospitalisation and mortality, 2. Utilisation of healthcare resources and 3. PRO measures, primarily quality of life (Euroqol EQ-5D) and illness perception (Brief Illness Perception Questionnaire (BIPQ). Discussion Benefits and possible drawbacks of the PRO-based follow-up will be evaluated. If PRO-based follow-up proves non-inferior to usual outpatient follow-up, a reorganisation of routine clinical practice in nephrology outpatient clinics may occur. Further, results may impact other patient groups with chronic conditions attending regular follow-up. Trial registration ClinicalTrials.gov identifier NCT03847766 (Retrospectively registered on January 23, 2019).

In view of the COVID-19 pandemic, there is an unmet clinical need for the guidelines on vaccination of patients with autoimmune inflammatory rheumatic diseases (AIIRD). This position paper summarises the current data on COVID-19 infection in patients with AIIRD and development of vaccines against COVID-19, discusses the aspects of efficacy and safety of vaccination, and proposes preliminary considerations on vaccination against COVID-19 in patients with AIIRD, mainly based on the expert opinion and knowledge on the use of other vaccines in this population of patients.

Objective To analyse how non-adherence to prescribed treatments might be prevented, screened, assessed and managed in people with rheumatic and musculoskeletal diseases (RMDs).Methods An overview of systematic reviews (SR) was performed in four bibliographic databases. Research questions focused on: (1) effective interventions or strategies, (2) associated factors, (3) impact of shared decision making and effective communication, (4) practical things to prevent non-adherence, (5) effect of non-adherence on outcome, (6) screening and assessment tools and (7) responsible healthcare providers. The methodological quality of the reviews was assessed using AMSTAR-2. The qualitative synthesis focused on results and on the level of evidence attained from the studies included in the reviews.Results After reviewing 9908 titles, the overview included 38 SR on medication, 29 on non-pharmacological interventions and 28 on assessment. Content and quality of the included SR was very heterogeneous. The number of factors that may influence adherence exceed 700. Among 53 intervention studies, 54.7% showed a small statistically significant effect on adherence, and all three multicomponent interventions, including different modes of patient education and delivered by a variety of healthcare providers, showed a positive result in adherence to medication. No single assessment provided a comprehensive measure of adherence to either medication or exercise.Conclusions The results underscore the complexity of non-adherence, its changing pattern and dependence on multi-level factors, the need to involve all stakeholders in all steps, the absence of a gold standard for screening and the requirement of multi-component interventions to manage it.

Objectives: The objective of this study was to evaluate the costs and consequences of introducing "self-administration of medication" (SAM) during hospitalization as compared with nurse-led dispensing and administration of medication. Methods: This pragmatic randomized controlled trial was performed in a Danish Cardiology Unit. Patients ⩾18 years old capable of self-administering medication were eligible. In the intervention group, patients self-administered their medication. In the control group, medication was dispensed and administered by nurses. The implementation of SAM was used to evaluate the cost–consequences. The micro-costing analysis used the hospital perspective and a short-term incremental costing approach. The costs for medication, materials, and nursing time were included. Consequences included the dispensing error proportion, patients’ perceptions regarding medication, satisfaction, and deviations in the medication list at follow-up. In addition, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge was included. Results: The total cost (TC) per patient in the intervention group was 49.9€ (95% CI: 46.6–53.2) compared with 52.6€ (95% CI: 46.6–58.6) in the control group. The difference between the groups was not statistically significant ( p = 0.09). Sensitivity analysis consistently showed TCs favoring the intervention. The dispensing error proportion was 9.7% (95% CI: 7.9–11.6) in the intervention group compared with 12.8% (95% CI: 10.9–15.6) in the control group. The difference was statistically significant ( p = 0.02). The analysis also found changes in the perceptions regarding medication (indicating higher medication adherence), increased satisfaction, and fewer patients with deviations in the medication list at follow-up. No statistically significant differences between the groups in relation to readmissions and GP contacts within 30 days were observed. Conclusions: SAM seems to cost less although the cost difference was small and not statistically significant. As SAM had positive effects on patient outcomes, the results indicate that SAM may be cost-effective. Plain language summary Self-administration of medication: a research study of the costs and consequences Objectives To evaluate the costs and consequences of introducing “self-administration of medication” (SAM) during hospitalization compared to medication dispensed by nurses. Methods This research study included patients ≥18 years capable of self-administering medication and was performed in a Danish cardiology unit. Patients self-administered their own medication during hospitalization in the intervention group, whereas nurses dispensed and administered the medication in the control group. Patients were allocated between groups by randomization. The costs of SAM were analyzed from a hospital perspective and included costs for medication, materials, and nursing time. The consequences included the proportion of dispensing errors, patients’ perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge. Results The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p = 0.09). The cost difference between groups was not significant. The proportion of dispensing errors was significantly lower in the intervention group compared to the control group. In addition the research study found changes in the perceptions regarding medication, increased satisfaction, and fewer patients with deviations in the medication list at follow-up. For readmissions and GP contacts within 30 days no significant differences between groups were found. Conclusion SAM cost less or equal to medication dispensing and administration by nurse. SAM had positive impacts on patient outcomes. Therefore, SAM may be cost-effective.

Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing. Methods: A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors. Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital. Lay Summary Self-administration of medication: a research study of the impact on dispensing errors, perceptions, and satisfaction Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with medication dispensed by nurses. Methods: A research study was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. Participants were allocated between groups by chance selection. The primary result of interest was the proportion of dispensing errors collected through observation of participants and nurses. Secondary results of interest were explored through telephone calls to determine participant perceptions regarding medication, participant satisfaction, and deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group compared with the control group. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: The reduced number of dispensing errors in the intervention group indicates that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction.

Objective Rheumatoid arthritis (RA) is a known risk factor for developing coronary artery disease (CAD). The influence of RA on the prognosis after initial CAD diagnosis and treatment is however largely unknown. We examined the risk of major cardiovascular events among RA and non-RA patients with chest pain referred to cardiac CT.Methods This was a follow-up study, using data from the Western Denmark Heart Registry, containing data on CT angiography examinations (Cardiac CT). Information on RA diagnosis and covariates were identified through nationwide administrative registers. The primary outcome was a combined outcome including, myocardial infarction, ischaemic or unspecified stroke, coronary artery bypass grafting, percutaneous coronary intervention, and all-cause mortality. Median time until events or censoring was 3.5 years (min/max: 0.0: 9.2). Cox proportional hazard models were used to examine the association between RA/non-RA patients and outcomes.Results Among 42 257 patients, referred between 2008 and 2016, we identified 358 (0.8%) with RA. An increased risk was seen in RA compared with non-RA (adjusted HR 1.35, 95% CI 0.93 to 1.96). Among patients who had received flare treatment more than once prior to cardiac CT the adjusted HR 1.80 (95% CI 1.08 to 3.00), and among patients with seropositive RA the adjusted HR 1.42 (95% CI 0.93 to 2.16).Conclusion In patients referred to cardiac CT due to chest pain, we found a trend of an association between RA and the combined primary outcome, supporting that RA per se, but in particular seropositive and active RA, may increase the risk of CAD even after initial CAD diagnosis and treatment.

Abstract Background The generic questionnaire WHO-5 Well-being Index (WHO-5), which measures the construct of mental well-being has been widely used in several populations across countries. The questionnaire has demonstrated sufficient psychometric properties; however, the test- retest reliability of the WHO-5 scale has yet to be determined. The aim of this study was to evaluate the test-retest reliability and measurement error of the Danish WHO-5 Well-being Index for outpatients with epilepsy. A further aim was to evaluate whether the method of administration (web, paper, or a mixture of the two modalities) influenced the results. Methods Epilepsy outpatients aged ≥15 years from three outpatient clinics in Central Denmark Region were included from August 2016 to April 2017. The participants were randomly divided into four test-retest groups: web-web, paper-paper, web-paper, and paper-web. Test-retest reliability was assessed by intraclass correlation coefficients (ICC) and measurement error by calculating minimal detectable change (MDC) on the basis of the standard error of the measurement. Results A total of 554 patients completed the questionnaire at two time points. The median duration between test-retest was 22 days. The pooled test-retest reliability estimate was ICC 0.81 (95% CI 0.78; 0.84). The estimated MDC was 23.60 points (95% CI 22.27; 25.10). These estimates showed little variation across administration methods. Conclusions WHO-5 showed acceptable test-retest reliability in a Danish epilepsy outpatient population across different method of administration; however, the relatively large measurement error should be taken into account when evaluating changes in WHO-5 scores over time. Further research should be done to explore these findings.